Search results for " contract development and manufactu…"
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Contract Manufacturing Through the Years
Contract Manufacturing Through the YearsHow has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hoHow has the bio/pharmaceutical contract ma…
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Maximum Output Starts with Optimized Upstream Processing
By Cynthia A. Challener
Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.
Significant growth in the develo…
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Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
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Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
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Science Focus Fuels Successful Process Development for Startups
Getting the science right helps biopharma startups overcome development and commercialization challenges.
By Cynthia A. Challener
sdecoret/Stock.Adobe.com
Pr…
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Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
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Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
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Modular Manufacturing Platforms for Biologics
May 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 5
It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…
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Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
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Mapping a Route for Cell and Gene Therapy Process Development
The focus for many manufacturers, whether innovators or contract development and manufacturing organizations (CDMOs), is on automation. “Many CDMOs are now integrating sufficiently flexible production…